Evaluation of Amniotic-Derived Membrane Biomaterial as an Adjunct for Repair of Critical Sized Bone Defects

摘要

Introduction. Autogenous bone graft is the gold standard in reconstruction of bone defects. The use of autogenous bone graft is problematic because of limited bone as well as donor site morbidity. This study evaluates a novel biomaterial as an alternative to autogenous bone graft. The biomaterial is amniotic membrane, rich in growth factors.Methods. Twenty-one adult male Sprague-Dawley rats were implanted with biomaterial using the rat critical size femoral gap model. After creation of the critical size femoral gap animals were randomized to one of the following groups:Group 1 (control): gap left empty and received no treatment;Group 2 (experimental): the gap was filled with commercially available bone graft;Group 3 (experimental): the gap was filled with bone graft plus NuCel amniotic tissue preparation.Results. The experimental groups demonstrated new bone formation compared to controls. The results were evident on radiographs and histology. Histology showed Group 1 controls to have 11.1% new bone formation, 37.8% for Group 2, and 49.2% for Group 3. These results were statistically significant.Conclusions. The study demonstrates that amniotic membrane products have potential to provide bridging of bone defects. Filling bone defects without harvesting autogenous bone would provide a significant improvement in patient care.